Defining and grading infections in clinical trials involving hematopoietic cell transplantation: A report from the BMT CTN Infectious Disease Technical Committee Journal Article
| Authors: | Shahid, Z.; Etra, A. M.; Levine, J. E.; Riches, M. L.; Baluch, A.; Hill, J. A.; Nakamura, R.; Toor, A. A.; Ustun, C.; Young, J. A. H.; Perales, M. A.; Epstein, D. J.; Murthy, H. S. |
| Article Title: | Defining and grading infections in clinical trials involving hematopoietic cell transplantation: A report from the BMT CTN Infectious Disease Technical Committee |
| Abstract: | The Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) was established in 2001 to conduct large multi-institutional clinical trials addressing important issues towards improving the outcomes of HCT and other cellular therapies. Trials conducted by the network investigating new advances in HCT and cellular therapy not only assess efficacy but require careful capturing and severity assessment of adverse events and toxicities. Adverse infectious events in cancer clinical trials are typically graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). However, there are limitations to this framework as it relates to HCT given the associated immunodeficiency and delayed immune reconstitution. The BMT-CTN Infection Grading System is a monitoring tool developed by the BMT CTN to capture and monitor infectious complications and differs from the CTCAE by its classification of infections based on their potential impact on morbidity and mortality for HCT recipients. Here we offer a report from the BMT CTN Infectious Disease Technical Committee regarding the rationale, development, and revising of BMT-CTN Infection Grading System and future directions as it applies to future clinical trials involving HCT and cellular therapy recipients. © 2024 The American Society for Transplantation and Cellular Therapy |
| Keywords: | disease classification; clinical trials as topic; clinical practice; infection; clinical assessment; morbidity; hematopoietic stem cell transplantation; health care policy; disease severity; severity of illness index; cell therapy; immune deficiency; immunosuppressive treatment; mycosis; clinical trials; infectious complication; clinical assessment tool; immune reconstitution; hematopoietic cell transplantation; randomized controlled trial (topic); clinical trial (topic); adverse event; grading; infections; mortality rate; Common Terminology Criteria for Adverse Events; humans; human; article; blood and marrow transplant clinical trial network infection grading system |
| Journal Title: | Transplantation and Cellular Therapy |
| Volume: | 30 |
| Issue: | 5 |
| ISSN: | 2666-6375 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2024-05-01 |
| Start Page: | 540.e1 |
| End Page: | 540.e13 |
| Language: | English |
| DOI: | 10.1016/j.jtct.2024.03.001 |
| PUBMED: | 38458478 |
| PROVIDER: | scopus |
| PMCID: | PMC11217895 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work